New Antimicrobial Approved by Committee
Paratek Pharmaceuticals, Inc (Boston, MA), announced that the Antimicrobials Drug Advisory Committee of the Food and Drug Administration (FDA) approved the use of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections. The drug is a modernized tetracycline developed as a once-daily broad spectrum antibiotic.
In its approval, the committee considered data from the omadacycline global development program, a series of three Phase 3 studies evaluating the safety and efficacy of the drug’s IV and oral formulations. All 3 studies found that primary and secondary efficacy outcomes, as determined by the FDA, were met and that the drug was generally safe and well-tolerated.
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